Many drugs administered to patients comprise a compound of medicament components mixed shortly before use. Oftentimes it is necessary to store these substances in separate receptacles until use. Reconstitution of the compound may require the mixing of a liquid-phase component and a solid-phase component, or the mixing of two liquid-phase components. Commonly, the solid-phase component is in powder form to permit stable storing of a component. The receptacles used to store these components may be constructed of glass, plastic, or other suitable material.
One way currently used to reconstitute material requires a first component to be injected with a syringe into a receptacle containing a second component. For example, a syringe having a needle attached thereto is inserted through the rubber membrane top of a receptacle containing a first liquid-phase component, and the liquid-phase component is withdrawn into the syringe barrel. The needle is then removed from the liquid-phase component receptacle. Subsequently, the needle of the syringe is inserted through the rubber membrane top of the second liquid-phase or solid-phase component receptacle, and the liquid-phase component is injected from the syringe barrel into the second receptacle. The second receptacle is shaken to mix the components. Thereafter, a needle, attached to a syringe, is inserted through the rubber membrane top, the component mixture is drawn into the syringe barrel, and the needle is removed from the receptacle. The component mixture may then be administered.
An improvement to this process is the subject of U.S. Pat. No. 5,445,631, entitled xe2x80x9cFluid Delivery Systemxe2x80x9d, to Tadatoshi et al. The device of that invention includes a double-ended spike containing a lumen. The problem created by the device disclosed therein failed to address pressurize equalization between the individual component containers. As a result, the rate of material transfer is in constant fluctuation due to thermodynamic issues.
These problems were addressed in WO 96/29112, entitled xe2x80x9cFluid Control Devicexe2x80x9d, to Handelman et al. The Handelman device utilizes pressurized component vials storing their contents under a high vacuum to create a pressure differential.
With respect to these devices, it is desirable to have a system capable of reconstituting a multiple component material using commercially available component storage receptacles. Additionally, it is desirable to have a reconstitution system wherein the operator may control the rate of reconstitution. Yet another problem associated with drug reconstitution is that some drugs, e.g. drugs used for chemotherapy, may be hazardous to hospital personnel. It is, thus, also desirable to have a reconstitution device and method that reduces or eliminates the possibility of inadvertent needle sticks.
The present invention discloses a method and apparatus for reconstituting a multiple component material. More particularly, the present invention discloses a method and apparatus utilizing an operator-controlled pressurization differential to transfer and reconstitute solutions. The individual components may comprise liquid-liquid, or liquid-solid mixtures. For example, the present invention is especially useful for reconstituting a fibrinogen-based tissue sealant. Another use of the present invention involves the reconstitution of multiple component chemotherapy drugs. In sum, the present invention in its broadest sense should not be construed to be limited to any particular multiple component materials, although particular examples may be shown and disclosed.
In one embodiment, a first receptacle receiver having at least a material flow lumen and a pressure lumen in communication therewith is in fluid communication with a second receptacle receiver through said material flow lumen. A user-controllable source of positive pressure is used to create a pressurization differential between the first and second receptacles, thereby resulting in transfer of the materials.
In yet another embodiment, a first receptacle receiver having at least a material flow lumen in communication therewith is in fluid communication through said material flow lumen with a second receptacle receiver having a pressure lumen in communication therewith. A user-controllable source of negative pressure is used to create a pressurization differential between the first and second receptacles, thereby resulting in a material transfer.
Also disclosed in the present invention is a method of reconstituting a solution, comprising the steps of creating fluid communication between a first receptacle and a second receptacle, and creating a pressure differential between said first receptacle and said second receptacle, thereby causing the contents of the first receptacle to flow into said second receptacle.
Other objects, features, and advantages of the present invention will become apparent from a consideration of the following detailed description.